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Be an investigator

Be an investigator

THE MyPeBS CLINICAL STUDY WILL BEGIN

IN DECEMBER 2018

MyPeBS could potentially change breast cancer screening in Europe. Investigators have the crucial role to inform women about the trial and include them in MyPeBS. Do you want to participate as an investigator to this unique pragmatic, community-based clinical trial?

Investigators’ skills

MyPeBS is a major ambitious European initiative. This unique international clinical study compares a personalised risk-based screening strategy to standard screening among women aged 40 to 70 in 5 countries: Belgium, France, Israel, Italy and UK. Its total duration is 6.5 years (2.5 years of recruitment and 4 years of follow-up per participant).

MyPeBS aims at potentially changing the future standard breast cancer screening. It is therefore embedded into the current organised screening of each country.

MyPeBS runs as a pragmatic, community-based clinical trial. Investigators are therefore doctors (and health professionals, according to countries) from the community.

Investigators are doctors (in some countries, other health professionals can also be investigators) with knowledge and practice in breast cancer screening.
They can be radiologists, general practitioners or gynaecologists.

They need to be well informed of the current standards and practices in terms of breast cancer screening. They must have communication skills in order to inform women not only of the trial, but also on the benefits and risks of screening.

They may have a previous experience of clinical research and trials. This is not absolutely required since MyPeBS is a pragmatic, community-based, trial.

How shall I proceed to become
an investigator of MyPeBS?

First check that you work in a region where MyPeBS runs.
Please send an email to investigator@mypebs.eu with :
– your name
– your centre or practice’s contact information
– a scan copy of you signed and dated CV, which must include your national practice registration number.

Upon verification of your eligibility as an investigator, the sponsor of the trial (Unicancer) will send you a research agreement to be signed. It will include the financial compensation for your participation to the study.

You will be asked to go through an online training on MyPeBS platform about the study (e-learning).
You will also be asked to have recently validated a Good Clinical Practice training (within the last 2 years). This training is available online on MyPeBS platform if necessary.
Eventually, you will be asked to take a short quizz to validate your training. This overall should take around 30 minutes.

The sponsor (Unicancer) will submit your CV to your national/regional ethics committee and declare you as a future investigator of the trial. Upon approval from your national/regional ethics committee, you will be able to exert as an investigator of the study and recruit women in the trial.

You will then receive from the trial Sponsor your personal codes to enter and use the MyPeBS webplarform. Having a secured private access to MyPeBS’ portal will allow all your activities within the trial. You will need to have a personal password. Please keep it absolutely secret and secured as indicated.

Be an investigator of MyPeBS:

what does it imply?

The investigators’ medical tasks in MyPeBS are the following:

  • Inform potentially eligible women about the trial :
  • Explain the trial to all women interested to participate
  • Check inclusion and exclusion criteria of women interested to participate
  • Have eligible women sign an electronic informed consent form, and sign it
  • Fill-in a few baseline data to create each new participant’s file in MyPeBS webplatform
  • Help women fill-in their initial questionnaires eventually
  • Randomize women into the trial and immediately inform them on the randomization result
  • For women randomized into the standard screening arm, give them their standard screening protocol: they will not have other appointments with you regarding the study (they will be followed online)

 

  • For those randomized into the risk-based screening arm, give them the saliva kit. They will provide you immediately with the saliva sample. This sample must be rapidly sent by standard mail for central DNA analyses(genotyping)
  • For the women randomized into the risk-based screening arm, you must give them a second appointment around 3 months later: at this second visit, you will inform them of their risk estimation and proposed screening program for the next 4 years.
  • For those randomized into the risk-based screening arm, please collect a saliva sample from them for future genotyping analysis; then give them a second appointment around 3 months later: at this second visit, you will inform them of their risk estimation and proposed personalized screening program for the next 4 years.
  • Answer potential participants’ questions regarding their participation and the trial throughout the 4 years follow-up

Screening structures participating in the trial

Cambridge University Hospitals NHS Foundation Trust

Hills Rd, Cambridge CB2 0QQ, Royaume-Uni

Manchester University NHS Foundation Trust

Southmoor Rd, Wythenshawe, Manchester M23 9QZ, Royaume-Uni

The Leeds Teaching Hospitals NHS Trust

Beckett St, Leeds LS9 7TF, Royaume-Uni

ADECA 75 - Centre de dépistage de Paris

82 rue Beauboug
PARIS 75003
01 48 42 77 01

ADC 77 - Centre de dépistage de Seine-et-Marne

333 rue Marguerite Perey CS 50058
LIEUSAINT 77563
01 60 62 47 01

ADMY - Centre de dépistage des Yvelines

18 avenue Dutartre
BP 120
LE CHENAY 78153
01 39 23 99 79

ADMC 91 - Centre de dépistage de l'Essonne

Centre hospitalier de Bligny
CS30365
FONTENAY LES BRIIS 91640
01 64 90 75 82

ADK 92 - Centre de dépistage des Hauts-de-Seine

26 rue des Amandiers
NANTERRE 92000
01 41 37 23 08

26 rue des Amandiers
NANTERRE 92000
01 41 37 23 08

CDC 93 - Centre de dépistage de la Seine-Saint-Denis

41 rue de Verdun
BONDY 93146
01 55 89 09 31

ADOC 94 - Centre de dépistage du Val-de-Marne

Le Parangon
68 rue de Paris
JOINVILLE LE PONT 94340
01 55 12 03 23

PSVO - Centre de dépistage du Val-d'Oise

14A avenue du Centaure
CERGY SAINT CHRISTOPHE 95800
01 34 24 57 11

ARDOC - Centre de dépistage du Cantal de la Haute-Loire et du Puy-de-Dôme

7 rue Edith Piaf
CLERMONT-FERRAND 63039

ADEMAS 69 - Centre de dépistage du Rhône

5 bis rue Cleberg
LYON cedex 05 69322
04 72 84 65 33

ODLC 01 - Centre de dépistage de l'Isère et de l'Ain

12 rue d la Grenouillère
BOURG EN BRESSE 01000
04 74 45 30 31

ODLC - Centre de dépistage de l'Isère et de l'Ain

19 chemin de la Dhuy
CS 70139
MEYLAN 38244
04 76 41 42 73

ADEMA80 - Centre de dépistage de la Somme

7 rue Jean Calvin
CS 78411
AMIENS 80048
03 22 90 64 93

Opaline 62 - Centre de dépistage du Pas-de-Calais

70 rue Mollien
CALAIS 62100
03 21 19 04 14

AISNE PREVENTIS - Centre de dépistage de l'Aisne

10 rue Jean Martin
LAON 02000
03 23 23 58 48

ADECASO - Centre de dépistage de l'Oise

2 rue Niepce
Les tertiales Bat C
BP80041
COMPIEGNE 60321

ADCN - Centre de dépistage du Nord

123 rue de Condé
LILLE 59005
03 20 06 38 12

AMODEMACES - Centre de dépistage de la Moselle

16 rue Graham Bell
METZ 57070
03 87 76 08 18

Gard Lozère dépistage

42 rue du Forez
BP 99034
NIMES cedex 9 30971
04 66 21 76 50

DOC 31 - Centre de dépistage de la Haute-Garonne

22 rue Guillemin Tarayre
TOULOUSE 31950
05 34 41 91 31

AGIDECA - Centre de dépistage de la Gironde

Bât C 21 avenue du Président Kennedy
CS 20015
MERIGNAC 33692
05.57.29.14.60

DOCVIE 86 - Centre de dépistage de la Vienne

203 route de Gençay
SAINT-BENOIT 86280
05 49 47 21 60

ORCHIDEE - Centre de dépistage de la Charente

10 chemin de Frégueneuil
SOYAUX 16800
05 45 68 30 21

EMMA - Centre de dépistage de la Seine-Maritime

42 rue des Chouquettes
YVETOT 76190
02 35 96 49 87

ADCA 84 - Centre de dépistage du Vaucluse

106 avenue de Tarascon
AVIGNON 84000
04 32 74 16 73

CAP SANTE 44 - Centre de dépistage de la Loire-Atlantique

50 route de St Sébastien
NANTES 44265
02 51 79 80 09

ADECAM - Centre de dépistage du Morbihan

14, allée François-Joseph Broussais

VANNES 56008
02 97 40 29 39

UZ LEUVEN

49 Herestraat
3000 Leuven

CHIREC

201 boulevard du Triomphe
1160 Bruxelles

HIS-IXELLES

38 rue Baron Lambert
1040 Bruxelle

BRUGMANN

4 place Arthur Van Gehuchten
1020 Bruxelles

SAINT PIERRE

322 rue Haute
1000 Bruxelles

UZ BRUSSEL

Avenue du Laerbeek 101
1090 Jette
Belgique

IJB

1 rue Heger-Bordet
1000 Bruxelles

CHWAPI

51 rue des Sports
7500 Tournai

CH JOLIMONT

159 rue Ferrer
7100 La Louvière

Assuta Medical Center Ramat HaHayal

20 HaBarzel St
Tel Aviv

Assuta Ra’anana

14 HaHaroshet St
Ra'anana 4365707

Assuta Hospital Rishon Lezion

13 Eliezer Mazal St
Rishon LeZion 75653

Assuta HaShalom – Tel Aviv

96 Yigal Alon St
Building C
Tel Aviv

Assuta Ashdod Medical Center

7 HaRefua St
Ashdod

Assuta Kalaniot – Ashdod

Kalanit Shopping Center
126 Menachem Begin St
Ashdod

Assuta Hospital Beer-Sheba

11 Yitchak Rager St
Building 7
Beersheba 84895

Assuta Haifa Hospital

HaHistadrut Ave 55
Haifa

Assuta Mobile Mammography Vehicle

96 Yigal Alon St
Building C
Tel Aviv

AUSL Reggio Emilia

Viale Umberto I°, 50
42123 Reggio Emilia (RE)

Coordinamento Screening. AUSL Reggio Emilia

Via Amendola 2
42122 - Reggio Emilia (RE)

SSD Epidemiologia Screening

Via Camillo Benso di Cavour 31
10123 Torino (TO)

SSD SENOLOGIA DI SCREENING Dipartimento Diagnostica per Immagini e Radioterapia

Via Cavour, 31
10123 Torino TO

Centro di Riferimento Regionale per la Prevenzione Oncologica

Universita di Firenze dipartimento dell area critica medico Chirur
Via delle Oblate, 4
50141 Firenze FI

Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori IRST Romagna

Via Piero Maroncelli, 40
47014 Meldola FC

IRCCS Policlinico San Donato

Via Rodolfo Morandi, 30
20097 San Donato Milanese MI
Italie

ATS Bergamo

Via Francesco Gallicciolli, 4
24121 Bergamo BG
Italie

Clinica Humanitas-Gavazzeni di Bergamo

Via Mauro Gavazzeni
24125 Bergamo BG

ASST Bergamo Est

Via Paderno, 21
24068 Seriate BG

ASST Bergamo Ovest

Piazzale Ospedale, 1
24047 Treviglio BG

ASST Papa Giovanni XXIII

Piazza OMS, 1
24127 Bergamo BG

ULSS 3 Serenissima

Via Don Federico Tosatto, 147
30174 Venezia VE

ATS Brescia

Viale Duca degli Abruzzi, 12
25124 Brescia BS